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A Study to Assess Beta-Lactam in the Treatment of Hospitalized Patients With Bacterial Pneumonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00111644
First received: May 24, 2005
Last updated: November 24, 2014
Last verified: November 2014

May 24, 2005
November 24, 2014
March 2005
January 2007   (final data collection date for primary outcome measure)
Clinical cure rate\n\n [ Time Frame: End of study visit (7-10 days after end of treatment) ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00111644 on ClinicalTrials.gov Archive Site
Adverse events, vital signs, laboratory parameters\n [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Study to Assess Beta-Lactam in the Treatment of Hospitalized Patients With Bacterial Pneumonia
A Randomized, Double-blind Study of the Effect of Beta-lactam on Treatment Response in Patients Hospitalized With Bacterial Pneumonia

This study will assess the efficacy and safety of intravenous beta-lactam, in co mparison with ceftriaxone, in hospitalized patients with community-acquired pneu monia not caused by Legionella. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pneumonia, Bacterial
  • Drug: Ceftriaxone
    1000mg iv daily
  • Drug: beta-lactam
    750mg iv q 23h for 3-14 days
  • Drug: beta-lactam
    1500mg iv q 12h for 3-14 days
  • Experimental: 1
    Intervention: Drug: beta-lactam
  • Experimental: 2
    Intervention: Drug: beta-lactam
  • Active Comparator: 3
    Intervention: Drug: Ceftriaxone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
302
January 2007
January 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • male or female patients at least 18 years of age;
  • hospitalization with community-acquired pneumonia or development of pneumonia within 48 hours of being hospitalized for another reason;
  • fever;
  • new or increased productive cough;
  • chest pain, shortness of breath, or rapid breathing.

Exclusion Criteria:

  • requiring intubation or ventilation;
  • nursing home or extended care within 60 days before study;
  • concomitant bacterial infection requiring antibiotics;
  • long-term immunosuppressive therapy.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Bulgaria,   Chile,   Croatia,   Hungary,   Latvia,   Lithuania,   Peru,   Romania,   Slovakia
 
NCT00111644
WI18273
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP